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STERISYS - Your Solution and Service Provider for Industrial Sterilisation

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STERISYS - About

STERISYS is the European leader in industrial EO sterilisation and offers a wide range of solutions to medical device manufacturers and sterilisation service providers.

We understand the challenges faced by our clients and the industry
STERISYS provides support to streamline sterilisation processes, increase
productivity and facilitate the growth of your company.

The healthcare industry strives to guarantee and steadily improve humanity’s wellbeing by enhancing medical treatments and developing precise technologies. While medical devices and pharmaceutical products are becoming progressively more complex, the industry simultaneously demands for more efficient, safe and reproducible production processes. With these advancements, industrial sterilisation requirements also constantly evolve.

At STERISYS we are eager to take on those challenges - day after day. We provide our customers with turnkey solutions for the safe and reliable sterilisation of their products. Thanks to our long-term industry experience we develop highly efficient, state-of-the-art sterilisation solutions.

The result: A sterilisation unit customized exactly to our customers’ needs and fully integrated into their existing processes.

sterisys

Complete portfolio for your sterilisation facilities
Alongside highly efficient turnkey sterilisation units, we offer all the ancillary process equipment such as:

  • External pre-conditioning and degassing (aeration) cells
  • EtO gas treatment units (catalytic abatement systems, scrubbers, …)
  • EtO monitoring system (gas chromatograph)
  • Integrated and fully centralised sysREG SCADA process control and monitoring system
  • Automatic conveyor and transportation systems

sterysis

STERISYS supports its customers in every project phase

Whether you need a requirement analysis, conceptual and development work, manufacturing, commissioning or maintenance of a sterilisation unit, you get everything from a single source.

Our highly qualified employees offer you comprehensive advice and stay by your side throughout every project phase to ensure a seamless integration and smooth operations. By using dynamic 3D CAD tools, we gradually refine the overall design of the customer’s sterilisation equipment.
Based on a process-oriented analysis, we determine together the type of sterilisation process and the dimensions of the unit that will suit requirements best. Most importantly, we base the decision upon how the solution can be integrated into our client’s existing infrastructure.

This early cooperation with the customer is fundamental as it constitutes one of the key success factors for the entire project.

Design and manufacturing - innovative, precise, quality certified

Our unique solution spectrum comprises the in-house production of the steriliser and the integration of all additional system components - supplied by carefully selected industry partners.

We seek to complement our wide-ranging solution portfolio by working with competent and reliable partners. In other words, a close cooperation with our carefully selected business partners is fundamental as this yields to the successful mastering of technology challenges and the satisfaction of the specific requirements of the sterilisation industry.

sterisys

Our sterilisation solutions’ main characteristics:

  • Modular configuration of the sterilisation chambers from 0.5m³ to 32 euro-pallets
  • Single or two-door layout (horizontal sliding, vertical opening or hinge door systems)
  • Turnkey sterilisers equipped with all peripheral units (i.e. vacuum unit, chamber heating skid, EtO-vaporizer, air and N2 pre-heating unit, steam supply unit, scale systems…)
  • State-of-the-art decentralised process control architecture
  • Adherence to ATEX, EN 1422, EN 11135, FDA and GAMP 5 standards as well as certified according to EN 13485/ISO 9001 standards
  • Parametrical validation solutions

On-site installation and commissioning

The optimal adjustment of the unit not only increases efficiency and reduces your operating costs, it also ensures compliance with specific environmental and occupational health and safety regulations. To ensure this STERISYS provides the following services:

  • Extensive FAT (Factory Acceptance Tests), IQ (Installation Qualification) and OQ (Operational Qualification) test phases according to EN1422 and EN11135 standards
  • Project and equipment documentation in accordance with CE standards and machinery directives
  • Comprehensive training for operators and the maintenance staff

Preventive maintenance and service

Our service and maintenance team will support you and ensure the maximum operational availability and service life of your sterilisation unit.

Moreover, we can also optimise your existing system - regardless of the manufacturer. We will update your unit with the latest technology, ensure that it meets current legal requirements and put you back on the road to long-term success.

Renowned for innovation
Whether you need a vacuum or overpressure process, we are one of the world’s leading experts in industrial EO sterilisation and we never cease to innovate. We recently developed a Dual-EO-steriliser, which has the ability to operate both overpressure and vacuum sterilisation cycles depending on the products to be sterilised.

Your benefits with STERISYS:

  • Expert advice and complete support from a prime contractor
  • Turnkey, ready-to-use sterilisation systems
  • Long-term viability and conservation of value, thanks to state-of-the-art components and proven industry standards
  • Use of modern 3D-CAD visualisation tools to design the best possible layout of your plant
  • High flexibility through efficient processes, modular design of the ancillary equipment and optimised material flow
  • Manufacturing of sterilisation units of all sizes, made to order in our factory in Belgium
  • Competent, on-site commissioning of equipment (includingIQ/OQ testing)
  • Precise project documentation
  • Comprehensive maintenance and service portfolio

sterisys

Contact
STERISYS Sàrl
Gruuss Strooss 33
L-9991 Weiswampach
Luxembourg
Tel.: +352 998 937 20
Email: i[email protected]
URL: www.sterisys.eu

Engineering Services

STERISYS provides complete customer support starting from the initial concept to the final commissioning and maintenance phases.

The consulting services start with the early assistance of the customer's plans to modify or improve existing installations or implement new sterilisation production capacities.

Design and Manufacturing of EtO

The steriliser is at the heart of the overall sterilisation process. This is the reason why STERISYS decided to design and manufacture its own sterilisers.

The steam sterilisers are available from a volume of 0.5m³. The standard net volume of the EtO sterilisers ranges from 1 to 32 pallets (other dimensions are available on request). The sterilisers can be delivered fully equipped with the technical process units including our own STERISYS sysREG process control software in order to assure best…

Logistics and Handling Solutions for Pre-filled Syringes Manufacturing

STERISYS also provides innovative handling solutions for pre-filled syringes manufacturing. Our systems have been designed to eliminate gaps in the production chain and reduce product risk.

The robotized production cell safely handles filled and nested syringes and transfers the nests to the appropriate stations, including sterilisation if needed. Some advantages of the systems are reusable components and pallets; scalable and modular system with small footprint; universal compatibility of all syringes, nests and tubs and many other positive factors. Our experts know…

Maintenance Services

Due to our wide range of experience STERISYS offers tailored and first class maintenance services for all kinds of EtO and steam based installations.

The high level of expertise of our staff allows for real knowledge transfer during servicing periods (and not just provide "after-sales" services).

Supply of the Entire Sterilisation Equipment

In addition to the in-house manufactured sterilisers, STERISYS is able to supply all related sterilisation process components and services including assembly and commissioning of the equipment at a customer's site.

To ensure best solutions and first service level, STERISYS is working in close cooperation with selected industrial partners. The extended STERISYS solution portfolio includes by example: External pre-conditioning and degassing (aeration) units EtO peak-shaver Catalytic converters (according German TA-Luft regulation) EtO monitoring systems Automatic chamber load and unload systems
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Logiciel de contrôle et supervision pour installations de stérilisation à l’EtO

Fabricant d'équipements de stérilisation à l'oxyde d'éthylène (EtO), STERISYS a développé son propre logiciel de supervision conformément aux directives GAMP...
18th September 2017
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